Development of a New HPLC Method for the Simultaneous Determination of Ticarcillin and Clavulanic Acid in Pharmaceutical Formulations

A new HPLC method has been developed and validated for the simultaneous determination of ticarcillin (TIC) and clavulanic acid (CA) in pharmaceutical formulations. The HPLC separation was achieved on a beta-cyclodextrin column (Cyclobond I, 250 x 4.6 mm, 5 microm) with methanol-16 mM pH 6.0 ammonium...

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Veröffentlicht in:Journal of AOAC International 2009-07, Vol.92 (4), p.1089-1094
Hauptverfasser: TSOU, Tai-Li, LEE, Chiu-Wey, WANG, Hsian-Jenn, CHENG, Ya-Chung, LIU, Yu-Tien, CHEN, Su-Hwei
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container_end_page 1094
container_issue 4
container_start_page 1089
container_title Journal of AOAC International
container_volume 92
creator TSOU, Tai-Li
LEE, Chiu-Wey
WANG, Hsian-Jenn
CHENG, Ya-Chung
LIU, Yu-Tien
CHEN, Su-Hwei
description A new HPLC method has been developed and validated for the simultaneous determination of ticarcillin (TIC) and clavulanic acid (CA) in pharmaceutical formulations. The HPLC separation was achieved on a beta-cyclodextrin column (Cyclobond I, 250 x 4.6 mm, 5 microm) with methanol-16 mM pH 6.0 ammonium acetate buffer (50 + 50, v/v) mobile phase at a flow rate of 0.8 mL/min. Detection was at 220 nm. Validation of the method was performed by evaluating specificity, robustness, accuracy, and precision. The calibration curves were linear in the range of 1-100 microg/mL for CA and 2-200 microg/mL for TIC. The LOQs based on the standard regression lines were 0.42 and 1.42 microg/mL for CA and TIC, respectively, and the LOD were 0.14 and 0.47 microg/mL, respectively. Total recoveries of synthetic mixtures (CA:TIC = 1:10, 1:15, and 1:30) were 99.25-100.99% for CA and 99.54-100.82% for TIC. Compared with the U.S. Pharmacopeia method, the proposed method has the advantage of a relatively low flow rate and short analysis time. The proposed method was successfully applied for the simultaneous determination of these two drugs in sterilized H20 and 5% dextrose injection solutions.
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subjects Anti-Bacterial Agents - analysis
Biological and medical sciences
Calibration
Chemical properties
Chemistry, Pharmaceutical
Chromatography, High Pressure Liquid
Clavulanic Acid - analysis
Drug Combinations
Drug Stability
Enzyme Inhibitors - analysis
Food industries
Fundamental and applied biological sciences. Psychology
High performance liquid chromatography
Hot Temperature
Identification and classification
Indicators and Reagents
Methods
Penicillin
Pharmaceutical Solutions
Reference Standards
Reproducibility of Results
Separation (Technology)
Ticarcillin - analysis
Ultraviolet Rays
title Development of a New HPLC Method for the Simultaneous Determination of Ticarcillin and Clavulanic Acid in Pharmaceutical Formulations
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